Slime Play / Slime Baff / Messy Play Gelicity UK Ltd. 5866

Slime Play / Slime Baff / Messy Play
Gelicity UK Ltd.
5866
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Product name Slime Play / Slime Baff / Messy Play
Product Code KK3301 / KK3302 / KK3303
Company (Customer) Name Gelicity UK Ltd.
Company (Customer) Gelicity House, Unit 27, Castle Park Industrial Estate, Flint,
Address CH6 5XA, United Kingdom
Company (Customer) Phone 01352 731010
Company (Customer) Fax
Company (Customer)
Responsible Contact
Other Contact Details
ADSL Reference 5866
CPSR Completion Date 15-10-2014 14:53:30
The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditional on the
Responsible Person complying with the conditions in the notes and any other purity restrictions listed.
Date and signature of safety assessor.
Signed:
Date:
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PART A
Quantitative & Qualitative Composition of the Cosmetic Product
INCI
Chemical name
CAS
EINECS
Concentration in
Formulation %
(w/w)
ACRYLAMIDE/SODIUM
ACRYLATE COPOLYMER
2-Propenoic acid, sodium salt,
polymer with 2-propenamide
25085-02-3
polymer
99.445000%
84929-27-1 /
8024-22-4
284-511-6 / -
0.500000%
3567-66-6
222-656-9
0.055000%
8004-92-0 /
94891-32-4 /
95193-83-2 /
68814-04-0
- / 305-632-3 /
305-897-5 / -
0.055000%
Function ANTISTATIC FILM FORMING
EU 2013 Regs III/66
VITIS VINIFERA SEED OIL
Vitis Vinifera Seed Oil is the fixed
oil, consisting primarily of the
glycerides of the fatty acids,
obtained by pressing the seeds of
the Red Grape, Vitis Vinifera L.,
Vitaceae
Function EMOLLIENT SKIN CONDITIONING
EU 2013 Regs Not Controlled
CI 17200
Disodium 5-amino-4-hydroxy-3-(p
henylazo)naphthalene-2,7-disulph
onate and its permitted lakes and
salts
Function COSMETIC COLORANT
EU 2013 Regs IV/1, 37 III/254
CI 47005
1H-Indene-1,3(2H)-dione,
2-(2-quinolinyl)-, sulfonated,
sodium salts; D & C Yellow no. 10
Function COSMETIC COLORANT
EU 2013 Regs IV/1
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INCI
Chemical name
CAS
EINECS
CI 42090
Dihydrogen (ethyl)[4-[4-[ethyl(3-sul
phonatobenzyl)]amino]-2'-sulphon
atobenzhydrylidene]cyclohexa-2,
5-dien-1-ylidene](3-sulphonatoben
zyl)ammonium, disodium salt
3844-45-9
223-339-8
Concentration in
Formulation %
(w/w)
0.009000%
Function COSMETIC COLORANT
EU 2013 Regs IV/1
Fragrance / Parfum Information
Name of Fragrance NONE PRESENT
Code of Fragrance
Fragrance Manufacturer
Physical/Chemical Characteristics & Stability of the Cosmetic Product
Physical Description Crystals
of the Product
Aroma Characteristic
Colour Various
Taste N/A
pH of Product N/A
Viscosity N/A
Specific Gravity N/A
Stability A stability test has not been supplied
INCI
Physical Description
Chemical description
ACRYLAMIDE/SODIUM
ACRYLATE COPOLYMER
White granular solid
2-Propenoic acid, sodium salt, polymer with
2-propenamide
Specific Gravity: ~0.75
pH: ~6-8 for 1% solution
Flash point: >200°C
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INCI
Physical Description
Chemical description
VITIS VINIFERA SEED OIL
Clear, pale yellow to green liquid with a
characteristic odour
A highly polyunsaturated triglyceride oil obtained
from the pressed seed of Vitis Vinifera L.,
Vitaceae
Free Fatty Acid (% as oleic): 0.5% Maximum
Specific Gravity @ 20° C: 0.9150 - 0.9240
Refractive Index: 1.473 - 1.476
Iodine Value: 123 - 143
Peroxide Value: 10 Meq/kg Maximum
Miscible with mineral oil and isopropyl esters.
Insoluble in water.
FATTY ACID PROFILE: (%)
Palmitic C16:0 6 - 8
Stearic C18:0 2.0 - 4.5
Oleic C18:1 15 - 25
Linoleic C18:2 62 - 75
CI 47005
Yellow powder
Emp. Formula : C18H10NNaO5S (principal
compound)
Mol weight : 375.3 g/mol (monosulfonic)
477.0 g/mol (disulfonic)
Melting point : >150ºC (decomposition)
Boiling point : /
Density : /
Rel. vap. dens. : /
Vapour Press. : /
Log Pow : 0.7
20% soluble in water, 5% soluble in saline, 2.5%
soluble in DMSO, 2% in standard formulation.
CI 17200
Dark red/brown powder
Formula: C16H11N3Na2O7S2
Molecular weight: 467
Log Pow: ≤ 0.5 (extrapolated)
Solubility: Water: > 2.5%; DMSO: > 10%; Ethanol: <
1%
CI 42090
Dark Violet powder
Emp. Formula : C37H34N2Na2O9S3
Mol weight : 792.86
Melting point : 283°C
Boiling point : 1184 °C (calculated by QSAR) *
Density : /
Rel. vap. dens. : /
Vapour Press. : 1.0 E-36 hPa (calculated by
QSAR) *
Log Pow : -0.32 (calculated by QSAR)
Solubility:
Water : > 20% (w/w) (pH 5.1)
DMSO : > 10% (w/w)
Acetone/water (1:1) : > 10% (w/w)
Ethanol/water (4:6) : > 10% (w/w)
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Microbiological Quality
Preservative Efficacy This product is anhydrous and inherently hostile to the growth of micro-organisms. Microbial
challenge testing is not required.
Plate Count
Impurities, Traces & Packaging
Description of the Packaging Packaging materials have not been submitted.
& Suitability for Use
Notes of Impurities, No impurities of concern have been identified in the raw material data supplied
Traces in the INCI
Normal & Reasonably Foreseeable Use
Description of Intended The product is added to a bath. It is a rinse-off product.
Application & Directions for Use
Exposure to the Cosmetic Product
Site of Application Area of body - area of head
Surface Area of 9000
Application (cm2)
Amount Applied (g) per day 0.873g
Duration Rinse-off
Frequency 1/day
Retention Factor 0.1
Exposure Routes Dermal (incidental ocular and oral)
Target Population Baby 15kg
Calculated relative daily 58.2
exposure (mg/kg bw/day)
Typical consumer use of the product is taken from the SCCS’s Notes of Guidance and the EPA Exposure Factors Handbook
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Exposure to the Substances
INCI
Calculated Relative
Daily Exposure
Concentration % (w/w)
Dermal Absorption
Systemic Exposure
Dosage
ACRYLAMIDE/SODIUM
ACRYLATE
COPOLYMER
58.2
99.445000%
100.000000%
57.87699
VITIS VINIFERA SEED
OIL
58.2
0.500000%
100.000000%
0.291
CI 47005
58.2
0.055000%
100.000000%
0.03201
CI 17200
58.2
0.055000%
100.000000%
0.03201
CI 42090
58.2
0.009000%
100.000000%
0.005238
Exposure data and method of calculation taken from the SCCS’s Notes of Guidance. The conventional conservative approach of assuming a
dermal absorption of 100% is taken where appropriate
Toxicological Profile of the Substances
Local Toxicity
INCI
Eye Irritant
Skin Irritant Skin
Irritant
Skin Sensitizer
Photo Sensitizer
Minimal
Minimal
No
No
No
No
No
No
CI 47005
Slight
Slight
No
No
CI 17200
No
No
No
No
CI 42090
Slight
Moderate
No
No
ACRYLAMIDE/SODIUM
ACRYLATE
COPOLYMER
VITIS VINIFERA SEED
OIL
Margin of Safety and Comments
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INCI
Margin of Safety (MOS)
NOAEL
SED
No Data
No data
57.87699
6117
1780
0.291
CI 47005
1562
50
0.03201
CI 17200
781
25
0.03201
120466
631
0.005238
ACRYLAMIDE/SODIUM
ACRYLATE
COPOLYMER
VITIS VINIFERA SEED
OIL
CI 42090
INCI
General Safety Comments
Data Reference
ACRYLAMIDE/SODIUM
ACRYLATE
COPOLYMER
Acrylamide/Sodium Acrylates Copolymer is a
polymer of 2-Propenoic acid, sodium salt with
2-propenamide. It functions as a film former and
anti-static in cosmetics and personal care
products. It has a very low order of acute toxicity.
It is a minimal ocular and dermal irritant but is not a
sensitiser. It is not classified as carcinogenic,
mutagenic or reprotoxic. Its use in personal care
products is regulated under Annex III/66 of the
Cosmetic Regulations such that (a) Body leave-on
products Maximum residual acrylamide content
0.1mg/kg, (b) Other products Maximum residual
acrylamide content 0.5mg/kg.
SCCS 0011/98 - Opinion concerning Acrylamide
Residues in Cosmetics
MSDS for Magnafloc® LT27AG from BASF
CORPORATION
VITIS VINIFERA SEED
OIL
Vitis Vinifera Seed Oil is the fixed oil, consisting
primarily of the glycerides of the fatty acids,
obtained by pressing the seeds of the Red Grape,
Vitis Vinifera L., Vitaceae. When used in cosmetics
and personal care products, Vitis Vinifera (Grape)
Seed Oil functions as a skin-conditioning agent
and emollient. It is practically non-toxic and is not
an irritant or sensitiser. It is not a carcinogen, a
mutagen, or reproductive toxin. It is safe to use in
its current application.
"Vitis Vinifera (Grape) Ingredients as Used in
Cosmetics", CIR, February 17, 2012
Technical Data sheet for VITIS VINIFERA (GRAPE)
SEED OIL from Jeen International Corp.
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INCI
General Safety Comments
Data Reference
CI 47005
CI 47005 or D&C Yellow 10 is a mixture of the
disodium salt of the mono- and disulfuric acids of
2(2-quinolyl)-1H-indene-1,3(2H)-dione. It is used as
a colourant in cometics and personal care
products. It is of very low acute toxicity and is
generally well tolerated in chronic exposure tests.
Some effects seen in rat pups during long-term
tests have lead to a cautious ADI of 0.5 mg/kg
bw/day based on a NOAEL of 50 mg/kg bw. It is
slightly irritating but not a sensitiser. It is not a
carcinogen, genotoxin, or reprotoxin. It is a
permitted food additive in the EU (E 104) where it
must conform to the specifications listed in the
food regulations. In the USA it is subject to
certification by the FDA and permitted for
colouring cosmetics and personal care products
including products intended to be used on the
lips, however it is not permitted for use in products
intended for use in the area of the eye. CI 47005
is considered safe in its present use and
concentration.
"OPINION OF THE SCIENTIFIC COMMITTEE ON
COSMETIC PRODUCTS AND NON-FOOD
PRODUCTS INTENDED FOR CONSUMERS
CONCERNING ACID YELLOW 3 COLIPA n° C54",
Adopted by the SCCNFP during the 28th plenary
meeting of 25 May 2004, SCCNFP/0789/04
"Scientific Opinion on the re-evaluation of
Quinoline Yellow (E 104) as a food additive", EFSA
Panel on Food Additives and Nutrient Sources
added to Food (ANS), EFSA Journal 2009;
7(11):1329
CI 17200
CI 17200 is the Colour Index number of a red
monoazo dye also known as D&C Red 33 or Acid
Red 33. It is used as a colorant in cosmetics and
personal care products. It has a low acute toxicity
profile and is reasonably well tolerated over long
term use. It is not an irritant or sensitiser. It is not
carcinogenic, mutagenic, or a reproductive /
developmental toxin. In the E.U. when used as a
hair dye substance in non-oxidative hair dye
products it is restricted to a maximum
concentration of 0.5%. CI 17200 is considered
safe in its current use and concentration.
SCCP (Scientific Committee on Consumer
Products), Opinion on Acid
Red 33, 18 December 2007
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INCI
General Safety Comments
Data Reference
CI 42090
CI 42090 is a synthetic dye produced using
aromatic hydrocarbons from petroleum. It is also
known as FD&C Blue No. 1. In addition to its use in
cosmetics and personal care products, CI 42090
is commonly used as a food colouring (E 133 in
Europe). Although it has previously been banned
in Austria, Belgium, Denmark, France, Germany,
Greece, Italy, Spain, Sweden, and Switzerland
among others it has been certified as a safe food
additive in the EU and is today legal in most of the
countries. It has an extremely low level of acute
and chronic toxicity and is not generally an irritant
or a sensitiser. It has the capacity for inducing an
allergic reaction in individuals with pre-existing
moderate asthma. CI 42090 is listed in Annex IV,
Part I (colouring agent allowed for use in cosmetic
products) of the Cosmetics Directive of the
European Union and may be used in all cosmetics
and personal care products provided it conforms
to the specifications listed in the food regulations.
When used in cosmetic products in the European
Union it must be called CI 42090. When used as a
hair dye substance in a non-oxidative hair dye
product it is restricted by Annex III/1,190 to a
maximum concentration of 0.5% in the finished
product.
"Evaluation and opinion on Acid Blue 9", THE
SCIENTIFIC COMMITTEE ON COSMETIC
PRODUCTS AND NON-FOOD PRODUCTS,
SCCNFP/0787/04, 23 April 2004
Undesirable Effects & Serious Undesirable Effects
None reported
Information on the Cosmetic Product
No further information submitted.
PART B
Assessment conclusion
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*** PROVISIONAL ***
No product specification, stability, or packaging materials information has been provided for this product. The following
assessment is contingent on this information being supplied and found to be satisfactory.
Colours have been assessed at their maximum concentration. This conservative approach ensures the highest safety of the
product in its several shades.
The evaluation of the data available on the product and the information about the ingredients for the claimed use do not indicate
a significant risk to users that outweighs any benefits of use. The clinical data indicate very low incidence of adverse events
The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditional
on the Responsible Person complying with the conditions in the notes and any other purity restrictions listed.
Labelled warnings and instructions of use
CAUTION! Children under 5 years must be supervised by an adult due to small parts. This is a non-edible product. Not to be
eaten. WARNING! Product will be slippery, take care when entering and exiting the bath. DO NOT STAND UP. Avoid contact with
eyes, if contact occurs, rinse with plenty of cold water. Seek medical advice if any problem persists.For sensitive skin, test a small
amount on the skin first. Keep packaging for future reference.Wash off thoroughly after use. DO NOT EAT. WILL NOT CLOG
DRAINS.
Reasoning
The toxicological data given in Part A section 8 indicate that the ingredients are safe for their intended use.
In general, the final product would not be considered an irritant or potential skin sensitiser if the total concentration of irritant
ingredients is less than 10% and the total concentration of skin sensitisers is less than 1%. These levels are not exceeded in the
product. The product does not contain any known photosensitising ingredients.
Assessor’s credentials and approval of part B
Mark Richard Bowes-Cavanagh BSc (Hons) App. Chem CSci CChem MRSC
Address: Green Pastures, Totnes Road, Collaton St. Mary, Paignton, Devon,U.K.
Further Education
1991 - 1994 University Of Plymouth. Drake Circus, Plymouth.
2nd Class BSc (HONS) - Degree in Applied Chemistry.
Specially Qualified In
Qualitative & quantitative analysis of Material, Bio-organic, Analytical, Environmental, Physical, Organic
and Inorganic chemistry.
Close liaison with industrial processes and particular attention was given on GLP and all inferences
recorded.
Synthetic work and analysis using FTIR, IP, GC-MS, GC, HPLC, H-NMR, ICP--MS and bioassay
preparations.
Final year dissertation entitled "Isothiocyanates of the Larval Cabbage Root Fly (D.Radicum) Attractants"
Career History
2000-Present Advanced Development & Safety Laboratories Ltd Paignton, Devon. TQ4 7PW.
Technical Director
Analysis and Signing-Off of Safety Assessments in accordance to Cosmetics Directives, EU, ASEAN,
Canada and FDA and to 2013 regulations.
Presentation of new products or raw materials to customers including point of sale, including new
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actives from In-Cosmetics and other trade shows.
Negotiation of price points and order details with both internal departments and customers through
procurement or sales.
Research & Development of new products, including sourcing of new ingredients, componentry and
fragrance.
Sourcing of all packaging connected to new products, enabling product to arrive on time at third party
manufacturers.
Management of bank accounts and supplier credit accounts.
Legal paperwork to enable smooth transfer of product to Far East and FDA in USA though their internal
governing bodies.
Creation of website and update including ePDQ selling facility.
Collation of orders with manufacturers including Quality Control and adherence to specifications.
Organizing Trade Shows including NEC Fairs, Regional shows and Oversea Trade shows e.g. Hong
Kong Beauty Show.
Consultancy with manufacturers to establish new ranges for both them and feasibility to be successful
on the market.
Preparation of stability testing on all products including product compatibility.
Strategy planning for both ECL and with consultancy to clients on better systems within their
organizations including training.
1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.
Technical Manager
2010-2012 LF Beauty
To manage the team to ensure products are developed to specified standards to meet customer and
company requirements ensuring that all relevant technical standards are applied.
Lead the R&D team and ensure close working relationships between R&D and key internal
departments: NPD, Process, Commercial, Purchasing
Manage workload to ensure product developments are in line with critical paths.
To keep abreast of new technology with a view to:
- introduction into existing products
- introduction into new products
- use in innovation presentations
- use in technical bulletins
Ensure that products developed by R&D are:
- Market focused
- Legal (according to claim and composition)
- Safe to use
- Stable (will not separate, discolour etc.)
- Can be manufactured consistently to specification
Assess external testing product development requirements. Ensure testing is focused, best value and
accurately costed.
To liaise with customers in order to provide them with required levels of technical support, backed by
the supply of all data, samples and specifications.
To liaise with outside suppliers in order to:
- find new sources of innovation
- find equivalent raw materials at competitive costs
- tested externally, where internal facilities are inadequate for the purpose
- at minimum cost
Assist as necessary in the development of the R&D budget.
Ensure R&D spending is in line with agreed budgets and that external testing is properly targeted.
Undertake succession planning within the department and ensure that sufficient developmental
training takes place.
To reduce failure rate in process through managing pilot production programme and troubleshooting
bulk production issues.
The management, leadership, performance management, development, recruitment and training of all
staff within the function to ensure that department performance and customer service are optimised.
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Technical Manager
1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ
Direct involvement with sales in initiating new projects and servicing the account.
Upgrading the company’s capabilities in order to achieve ISO 9001 by March 2000.
Appearance on The Shopping Channel to promote Bodyline Products because of my technical sales
skills.
Organized trade shows for Bodyline Group including, NEC Cosmetic Fair, Frankfurt show.
Operating and maintaining a discipline factory environment with close control of logistical planning.
Close liaison with technical departments of all customers to ensure product quality and safety is
paramount.
Develop customer accounts to enable maximum potential for both the customer and the company.
Drive the dynamic creative engine of the company to achieve franchise Bodyline shops in Europe and
Oceania.
Increase bottom line profit by efficiently programming in projects and maximizing the workforce to
achieve manufacturing wages lower ever before.
Maximize output due to cash flow considerations enabling Bodyline to invest in other project ventures.
Evaluate customer requirements to measure Bodylines to achieve maximum profit margin and to
enable projects capability of achieving product goal or sub-contracting to other contacts.
Close liaison with suppliers to accomplish cost saving initiatives to complete within the critical path.
Organizing meetings between departments and collaborating with managers to ensure a smooth
project path.
Research & Development Chemist
1999 - 1995 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.
Formulated a more comprehensive range of products to promote the Bodyline range within the cost
parameters and our animal testing declaration (1985).
Achieved suspensions for sophisticated skin care and innovative designs.
Produced varied emulsified systems according to customer requirements and production facilities.
Introduced new systems into the Research & Development arena to achieve high standards in
conjunction with EEC directives on stability and safety of products.
Researched into most commercially used preservatives within cosmetic sector according to product,
cost and customers needs.
Initiate point of sale and manufacturing information for customers on recommended applications and
benefits of product.
Oversee Quality Assurance to answer customer enquiries and required contingency measures.
Evaluation of all additives in product to achieve maximum stability and safety, to prolong shelf-life.
Zeneca Environmental Laboratory, Brixham, Devon.
Work Experience in Vertebrae Laboratory monitoring temperature, pH and other environmental
parameters.
Achievements
Member of the Royal Society Of Chemistry and a "Chartered"
Chemist and Scientist.
Member of The Society Of Cosmetic Scientists.
Member of the British Toxicology Society
Date and signature of safety assessor.
Signed:
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Date:
October 15, 2014
This assessment is based on information supplied by the client, raw material manufacturers and published information in recognised
authoritative sources. Whilst best endeavours have been used to check the accuracy of this information, the undersigned cannot be held
responsible for any erroneous information supplied and used for preparing this assessment.
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